Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis

An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01232543

Acronym

0405-01-04

Enrollment

114

Registered

2010-11-02

Start date

2010-11-30

Completion date

2011-11-30

Last updated

2012-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Brief summary

The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis

Detailed description

Treatment medication will be administered topically, twice a day for 4 weeks.

Interventions

DRUGProduct 0405

Product 0405 will be administered topically, twice daily for 28 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 17 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of Atopic Dermatitis * Good health with the exception of Atopic Dermatitis * Percent body surface area minimum requirements

Exclusion criteria

* Subjects who are pregnant, nursing, or planning a pregnancy

Design outcomes

Primary

Measure	Time frame
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.	4 weeks

Secondary

Measure	Time frame
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026